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Study of Acetaminophen (ACM) in Post-operative Dental Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02735122
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Johnson & Johnson Consumer and Personal Products Worldwide
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division )

Brief Summary:
This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.

Condition or disease Intervention/treatment Phase
Post Operative Dental Pain Drug: acetaminophen Tablet Drug: acetaminophen Caplet Drug: ibuprofen Liquid-filled capsule Drug: Placebo Tablet Drug: Placebo Caplet Drug: Placebo Liquid-filled capsule Phase 3

Detailed Description:
This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
Actual Study Start Date : April 30, 2016
Actual Primary Completion Date : October 5, 2016
Actual Study Completion Date : October 5, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test acetaminophen
acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
Drug: acetaminophen Tablet
2 test acetaminophen 500 mg tablets
Other Name: Test ACM

Drug: Placebo Caplet
2 placebo caplets

Drug: Placebo Liquid-filled capsule
2 placebo Liquid-filled capsules

Active Comparator: Commercial acetaminophen
acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
Drug: acetaminophen Caplet
2 commercial acetaminophen 500 mg caplets
Other Name: Commercial ACM

Drug: Placebo Tablet
2 placebo tablets

Drug: Placebo Liquid-filled capsule
2 placebo Liquid-filled capsules

Active Comparator: Commercial ibuprofen
ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
Drug: ibuprofen Liquid-filled capsule
2 commercial ibuprofen 200 mg Liquid-filled capsules
Other Name: Commercial IBU

Drug: Placebo Tablet
2 placebo tablets

Drug: Placebo Caplet
2 placebo caplets

Placebo Comparator: Placebo
Placebo tablet and placebo caplet and placebo liquid-filled capsule
Drug: Placebo Tablet
2 placebo tablets

Drug: Placebo Caplet
2 placebo caplets

Drug: Placebo Liquid-filled capsule
2 placebo Liquid-filled capsules




Primary Outcome Measures :
  1. Time to first confirmed perceptible pain relief [ Time Frame: 6 hours ]
    Minutes until confirmed first perceptible pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.


Secondary Outcome Measures :
  1. Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo) [ Time Frame: 30 minutes or less ]
  2. Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen) [ Time Frame: 10 minutes or less ]
    The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 10 minutes

  3. Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen) [ Time Frame: 15 minutes or less ]
    The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 15 minutes

  4. Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen) [ Time Frame: 20 minutes or less ]
    The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 20 minutes

  5. Percentage of subjects with meaningful relief by 30 minutes [ Time Frame: 30 minutes or less ]
  6. Time to meaningful pain relief [ Time Frame: 6 hours ]
    Minutes until meaningful pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subjects are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them.



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 17 years to 50 years old
  2. Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
  3. Dental extraction of three or four molars
  4. Experience moderate to severe pain after extraction of third molars
  5. Females of childbearing age must be willing to use acceptable method of birth control

Exclusion Criteria:

  1. Currently pregnant or planning to be pregnant or nursing a baby
  2. Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS)
  3. Inability to swallow whole large tablets or capsules
  4. Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735122


Locations
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United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
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Principal Investigator: Derek D. Muse, M.D. Jean Brown Research

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Responsible Party: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
ClinicalTrials.gov Identifier: NCT02735122    
Other Study ID Numbers: CO-151027203834-PACT
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At this time we do plan to share IPD through the YODA site. The specific individual participant data sets have not yet been determined.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action